Deep rTMS in Central Neuropathic Pain Syndromes

Pain Clinical Trial

— DRTMS  

Official title:

Deep rTMS in Central Neuropathic Pain Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932905
• Other study ID #: RGDCA-02
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: May 8, 2017
• Start date: March 2011
• Est. completion date: August 2015

Study information

• Verified date: May 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain affects up to 30% of the general population. In particular, neuropathic pain (NeP) is caused by lesion or desease affecting peripheral or central somatosensory pathways and affects 7% of the adult population. Despite the availability of evidence based pharmacological and surgical treatment for NeP, about 50% of patients remais symptomatic despite best medical treatment. Some neuropathic pain syndromes are specially refractory. In particular, central NeP is caused by disease or lesion to central structures involves in somatosensory integration of nociceptive information is non-responsive to drugs usually employed in other NeP syndromes. Classical neuromodulatory techniques such as conventional repetitive Transcranial Magnetic Stimulation aiming at the motor of prefrontal cortices are ineffective to relieve pain in this population. Recently new technology advances have made possible non-invasive stimulation of deeper cortical targets. Some of them are activelly involved in the integration of the perception of pain, such as the anterior cingulate cortex or the posterior insula. The aim this study is to treat 90 patients with central pain (post stroke pain, spinal cord lesions after trauma or demyelinizating diseases) under best medical pharmacological treatment in three different conditions: AAC (n= 30 with the H-Coil), Superior Posterior Insula (SPI) n=30 cooled double cone coil double cool coil, and sham(n=30). Each patients will undergo daily stimulation for a week, then weekly stimulations for 3 months (total of 17 sessions). The main study outcome is pain relief at the last stimulation week (visual-analogic scale). Secondary end-points are changes in the McGill Pain Questionnaire, Neuropathic Pain Symptom Inventory, DN4 questionnaire, SF -36, brief pain inventory and cognitive assessment including the trail making test A and B, Strrop color interference test, and subscalles from the CERAD. All patients will undergo quantitative sensory test and measurements of cortical excitability over M1 before and after to treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed term of informed consent

• central pain

Exclusion Criteria:

• Trauma of Skull, epilepsy don't treated,

• Use of medications decrease the seizure threshold

• Patients in use of drugs, how cocaine and alcohol

• neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)

• Pregnant or lacting women

Related Conditions & MeSH terms

• Neuralgia
• Pain
• Post Stroke Pain
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• deep rTMS
Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC/FMUSP)	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline of Pain	assessing by verbal analog scale (VAS)	base line (moment of inclusion) and end of each session rTMS (4X in three months)